1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct 31, 1990 to Dec 31, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to international guidelines and Good Laboratory Practice standards using the comemercial product as test article.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1991

Reference 2

Reference Type:

publication

Title:

Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test.

Author:

Ames et al.

Year:

1975

Bibliographic source:

Mutation Research 31:347-364.

Reference 3

Reference Type:

publication

Title:

Simple bacterial systems for detection mutagenic agents

Author:

Bridges BA

Year:

1972

Bibliographic source:

Laboratory Practice 21:413-419.

Reference 4

Title:

Revised methods for the Salmonella mutagenicity test

Author:

Maron DM, Ames BN.

Year:

1983

Bibliographic source:

Mutat Res. 1983 May;113(3-4):173-215.

Reference 5

Reference Type:

publication

Title:

Unnamed

Year:

2007

Materials and methods

Principles of method if other than guideline:

Ames et al. (1975); Maron and Ames (1983), Bridges (1972).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]

EC Number:

284-366-9

EC Name:

1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]

Cas Number:

84852-53-9

Molecular formula:

C14H4Br10

IUPAC Name:

1,2,3,4,5-pentabromo-6-[2-(2,3,4,5,6-pentabromophenyl)ethyl]benzene

Details on test material:

96.3% Decabromodiphenyl ethane
3.6 % Dodecabromodiphenyl ethane

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

other: TA1538 and E. coli uvrA was also included

Metabolic activation:

with and without

Metabolic activation system:

Arochlor-induced rat liver microsomes

Test concentrations with justification for top dose:

0, 333, 667, 1000, 333 and 5000 ug/plate

Vehicle / solvent:

dimethylsulfoxide

Details on test system and experimental conditions:

Test article tested at 5 dose levels with appropriate vehicle and positive controls in the presence and absence of microsomal activation. All dose levels of the test article, vehicle controls and positive controls were plated in triplicate. A second confirmatory asssay was performed.

Evaluation criteria:

To be positive, a test article must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article:
Strains TA1535, TA1537, TA1538: data sets judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value.
Strains TA98, TA100, and WP2 uvrA: data sets judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value.

Statistics:

Mean number of revertants/plate and standard deviation of the means.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No increase in revertant colonies was found at any dose level in the presence or absence of microsomal enzymes in either Salmonella or E. coli.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test article did not induce mutations.

Executive summary:

In the Ames assay, the tester strains used wereSalmonellaTA98, TA100, TA1535, TA1537, and TA1538, andE. coliWP2 uvrA (WP2A). Each strain was tested with and without a source of exogenous metabolic activation of Arochlor-induced rat liver microsomes. The dose levels were 0, 333, 667, 1000, 3333 and 5,000 ug/plate. Appropriate positive and negative controls were included. An independent re-test was included. No increase in revertant colonies was found at any dose level in the presence or absence of microsomal enzymes.